genetics insurance concordat

Concordat and Moratorium onGenetics and Insurance

March 2005

If you would like more copies of this document, please contact:

Department of Health652C Skipton House80 London RoadLONDON SE1 6LH

Tel: 020 7972 1518Fax: 020 7972 1717

Introduction

1. The Government and the insurance industryrecognise and wish to respond tounderstandable concerns about the potentialuse of personal genetic data by insurancecompanies. They consider that the relationshipbetween medical data and insuranceunderwriting should be proportionate andbased on sound evidence. They also acceptthe commercial principle that, unless otherwiseagreed, insurance companies should haveaccess to all relevant information to enablethem to assess and price risk fairly in theinterest of all their customers.

2. They agree to:

(i) create a policy framework (‘Concordat’) forcooperation that provides that insurers’use of genetic information is transparent,fair and subject to independent oversight,building on existing voluntary codes ofpractice;

(ii) extend the existing voluntary Moratoriumon insurers’ use of predictive genetic testresults by five years to 1 November 2011,and to review this Concordat in 2008.

3. This document provides a single high-levelpolicy agreement on the use of genetic testresults in insurance underwriting practices.It is informed by discussions between theAssociation of British Insurers, its membercompanies and the Government, the Geneticsand Insurance Committee (GAIC) the HumanGenetics Commission (HGC), patient groupsand other interested parties.

Background

4. Genetic testing is in its infancy and its longterm implications for insurance, preventativemedicine or treatment is indeterminate. Themajority of genetic tests confirm diagnoses ofill health and inform treatments. Suchdiagnostic testing falls into the same categoryas other clinical technologies. The Concordatis concerned only with the far smaller numberof tests used to predict future illness. Only inrecent years has it become possible to designtests that examine genetic material forchanges that may predict future disease. Evenwith such advances, very few tests can predictwith any certainty when an illness might begin,or how severe it might be. There remainconcerns that a minority of patients might bedeterred from taking predictive genetic tests,if they fear that insurance companies maydiscriminate against them unfairly on the basisof the test results. The Concordat addressesthose fears.

5. The Concordat preserves the principle that,unless otherwise agreed, insurance companiesshould have access to all relevant informationto enable them to assess and price risk fairlyin the interest of all their customers. So, if acustomer for life insurance knows (frommedical information, family history or tests) ofa specific risk to his or her health, it should inall normal circumstances be disclosed. If therisk is not disclosed, the insurance companymay face more, and more costly, claims than itwas able to assume in setting the price of itsinsurance policies. This could potentially affectthe future pricing or availability of insurancecover to all.

CONCORDAT AND MORATORIUM ON GENETICS AND INSURANCE 1


6. The current approach works in practicebecause the number of policies affected bynon-disclosure of predictive genetic test resultsis low. The moratorium allows customers whohave had adverse predictive genetic testresults to obtain significant levels of cover,whilst protecting the customers of individualinsurers from the consequences of extremelyhigh claims, which have not been priced for.

Purpose

7. The Concordat establishes a robust andflexible framework for cooperation between theGovernment and the Association of BritishInsurers and its members, and builds on thevoluntary Code of Practice alreadyimplemented by the Association. It is designedto balance societal concerns with the need fora commercially viable, long term and fairinsurance market. The Concordat sets out thepolicy on how predictive genetic tests may beused and creates strict arrangements for theiruse by:

l requiring higher standards of evidence ofincreased risk than apply to other forms ofmedical information used by insurers;

l subjecting the evidence to scrutiny andapproval by a Government appointedindependent committee;

l creating a rigorous compliance processbeyond the statutory and regulatoryrequirements; and

l creating an independent mechanismfor handling any complaints that falloutside the jurisdiction of the FinancialOmbudsman Service.

The Concordat and Moratorium protect theinterests of both customers and insurers, bypreserving customers’ access to insurance,and insurers’ right of equal access toinformation about risks.

Parties

8. The parties to this Concordat are theGovernment of the United Kingdom andDevolved Administrations (‘the Government’),and the Association of British Insurers (‘theABI’). The ABI is the trade association forBritain’s insurance industry. Its more than 400member companies provide over 97% of theinsurance business in the UK. TheGovernment is represented by the Secretariesof State for Health and Trade & Industry andthe Chancellor of the Exchequer.

9. Adoption of the Concordat is voluntary andis intended to be binding in honour only. It is astatement of intent and does not create legalobligations between the parties. However,some aspects, including the Moratorium, arein practice considered to be binding on allmember companies of the ABI, via its Codeof Practice.

10. Nothing in this Concordat should beconstrued as conflicting with statutoryrequirements or with other professional dutiesand obligations.

General principles

11. The parties to this Concordat agree thefollowing principles:

l Insurers should not treat customers whohave an adverse predictive genetic testresult less favourably than others withoutjustification;

l The technical, clinical and actuarialrelevance of predictive genetic test resultsshould be subject to independent oversightthrough GAIC;

l Customers should receive clearexplanations of their rights. They shouldhave access to a free, independent servicefor resolving complaints;

2 CONCORDAT AND MORATORIUM ON GENETICS AND INSURANCE

l Insurers and customers should have equalaccess to information that is material andrelevant for insurance underwriting, exceptas provided for by the Concordat and theMoratorium on access to predictive genetictests by insurers.

Predictive genetic tests

12. This agreement applies to predictivegenetic tests, which examine the structure ofchromosomes (cytogenetic tests) or detectabnormal patterns in the DNA of specificgenes (molecular tests). It does not apply tonon-genetic medical tests, for example bloodor urine tests for cholesterol, prostate cancer,liver function or diabetes.

13. GAIC has said that it will considerapplications to approve the use of predictivegenetic test results by insurers for conditionsthat are:

l Monogenic (single gene disorders that areinherited in a simple fashion);

l Late-onset (symptoms are delayed untiladult ages); and of

l High penetrance (a high probability thatthose with the gene will develop thedisorder).

Policy on the use of predictive anddiagnostic genetic test results

14. Insurers have agreed a set of measuresintended to reassure patients so that they arenot deterred from taking a predictive genetictest by fear of potential insuranceconsequences. The measures cover:

l the nature and detail of information soughtfrom customers;

l how insurers will handle informationprovided voluntarily by customers; and

l the use made of that information.

15. The ABI will continue to work with GAIC,patient interest groups and industrystakeholders to examine methods of improvingaccess to insurance for people with geneticdiseases through, for example, development ofstandardised information about rare geneticconditions to give a common evidence base tounderpin underwriting decisions.

Information sought from customers

16. Insurers agree that:

(i) Customers will not be asked to, nor be putunder any pressure to, undergo apredictive genetic test in order to obtaininsurance.

(ii) Customers will not be asked to discloseanother person’s predictive test results,such as a blood relative’s test.

(iii) Customers will not be asked to discloseany predictive or diagnostic genetic testresults acquired as part of clinicalresearch.

(iv) Customers will not be required to discloseany predictive genetic test results that aremade available after their policy hasstarted, for as long as that policy is inforce.

(v) Customers who have taken a predictivegenetic test before the date of thisConcordat will be treated in the same wayas customers taking tests under the termsof the Concordat.

(vi) Insurers are permitted to seek, withcustomers’ consent, access to certainfamily medical history, diagnostic (but notpredictive) genetic test results, and toreports from GPs in order to accuratelyprice the additional risk from any healthproblems an applicant discloses.


(vii) Customers can be asked by insurers todisclose the adverse results of predictivegenetic tests approved by GAIC underspecific conditions, when they apply forinsurance policies over the financial limitsof the moratorium.

(viii) Insurers have stringent procedures forseeking access to relevant medicalinformation held by a GP or otherclinician, agreed between the ABI andthe British Medical Association.

(ix) Insurers will protect personal medicalinformation in accordance with ABIGenetics Code.

(x) Insurers will destroy medical evidencewhen it is no longer relevant to them.

Handling of informationprovided voluntarily


(i) Customers may choose to disclosepredictive genetic test results that are intheir favour in order to over-ride familyhistory information. Individual insurancecompanies will publish information aboutthe way they will use such test results toinform their underwriting decisions.

(ii) Most insurance companies will take intoaccount the result of such a voluntarilydisclosed genetic test, even if it has notbeen approved by GAIC, provided thatthe result is from a reputable source.

Use of information


(i) They will not use information frompredictive genetic test results tounderwrite travel insurance, privatemedical insurance, or any other one-off orannual policy, or for long term carepolicies.

(ii) The broad classes of insurance for whichgenetic test results may be relevant areconfined to the following products:l life;l critical illness; andl income protection.

(iii) Where they make use of the results ofGAIC approved tests to impose specialterms or conditions, they will not imposeunjustified exclusions from cover, or otherspecial terms or conditions, which havethe effect of preventing a policyholderfrom making a claim for a condition that isnot related to the genetic conditionidentified by an approved test.

(iv) If a predictive genetic test is disclosed bymistake, insurers will ignore it.

The Moratorium

19. The Moratorium on insurers’ use ofpredictive tests is a key part of the overallConcordat. It makes an exception to theprinciple of disclosure. It allows patients whohave taken a predictive genetic test to obtainsignificant levels of cover without disclosingthe results of that test. Insurers have beenprepared to bear the risks and costs of non-disclosure, which are spread across the broadpool of policyholders, because the number ofpolicies affected by non-disclosure ofpredictive genetic tests is low. Accordinglythe insurance industry and Government haveagreed that the Moratorium should beextended.

20. The terms of the Moratorium are asfollows:

(i) Customers will not be required to disclosethe results of predictive genetic tests forpolicies up to £500,000 of life insurance,or £300,000 for critical illness insurance,or paying annual benefits of £30,000 forincome protection insurance (the ‘financiallimits’). More than 97% of policies issuedin 2004 were below these limits in eachcategory.


(ii) When the cumulative value of insuranceexceeds the financial limits, insurers mayseek information about, and customersmust disclose, tests approved by GAICfor use for a particular insurance product,subject to the restrictions in theConcordat.

(iii) The Moratorium will expire on1 November 2011, unless it is explicitlyrenewed through the Concordat.

Compliance

21. The ABI will continue to run an annualexercise assessing the compliance of itsmember companies with the ABI Code ofPractice and the Moratorium, the results ofwhich are published. GAIC will continue tocomment on this compliance report.Government and ABI will explore further andconsult GAIC and the HGC on the detailedaspects of the compliance and complaintssystem, in conjunction with the revision of theABI Code of Practice.

Code of Practice

22. The ABI will consult on and publish anupdated Code of Practice (“the Code”) layingdown the standards that insurers should meet.Compliance with the Code is a condition ofmembership of the ABI. The new Code willupdate the detailed arrangements for theinternal handling of genetic test results bynominated genetics underwriters and ChiefMedical Officers within companies. It will also setstrict standards for security and confidentiality ofmedical information. The ABI will revise andreissue the Code from time to time.

Resolution of disputes and complaints

23. Customers have the right to ask an insurerto provide information on whether, and if so,how, a predictive test result has contributed toan underwriting decision. They have the rightof appeal against an underwriting decision anda right to have a complaint heard fairly.

24. An insurer must tell a customer that theyhave the right to complain about a decisionwhere a predictive test result has beendisclosed and a customer believes that theyhave been unfairly treated. An insurer mustexplain the complaints process andadjudication system. It must investigate acomplaint and give the customer a writtendecision as soon as is practicable and withinthe time limits set for authorised insurers bythe Financial Services Authority.

25. Where a dispute is unresolved after thisprocess, a complaint may be made:

(i) under the terms of the FinancialOmbudsman Service, if a complainantbelieves that they have suffered or maysuffer financial loss, material distress ormaterial inconvenience as a result of aninsurer’s wrongful act or omission. Theservice, which is available to customersonce a contract is signed, is free tocustomers and decisions are binding oninsurers and complainants, subject to theright of insurers to seek judicial reviewor complainants to go to Court in thenormal way; or

(ii) to the ABI, who will look again at all thematerial facts and decide whether a breachof the Code, Concordat or Moratorium hasoccurred. The service is free to customersand is binding on insurers.

26. The ABI may refer cases to GAIC if it isunable to resolve them or if it believes that thecase has wider implications concerning genetictesting. Customers may also appeal to GAIC ifthe ABI is unable to resolve a complaint to thecustomer’s satisfaction about the way that aninsurer has dealt with their case.

27. The Committee will adjudicate on the useand interpretation of predictive genetic tests byinsurers. It may review the material evidenceand may seek further information beforereaching a decision. The service is free tocustomers and Insurers agree to be bound bydecisions taken by GAIC. However, theCommittee will not be able to give personal


advice about insurance, or to deal withcomplaints about the ABI process, about firmswhich are not insurance companies ormembers of the ABI, the operation of aninsurance policy, or an insurer’s proper useof its commercial judgement.

28. If a customer receives a final decision fromGAIC or from the ABI, with which they are notsatisfied, they may ask the ABI to convene anindependent tribunal under the terms of itsCode of Practice. The tribunal will beauthorised to fine companies and compensatecustomers, normally within six months. Thetribunal service is free to customers and isbinding on insurers.

29. In every case a customer’s legal rights areunimpaired. They remain free to take courtproceedings against an insurer at any time.

The Genetics and Insurance Committee(GAIC)

30. GAIC has developed and published thetechnical, clinical, and actuarial criteria forevaluating predictive genetic tests, theirapplication to particular conditions and theirreliability and relevance to particular types ofinsurance. GAIC’s core duty will remain that ofevaluating predictive genetic tests againstthose criteria and publicising its findings.

31. GAIC will provide independent, wide-ranging oversight of how insurers are usingpredictive genetic tests. It will continue toreport to Health, Treasury, and Department ofTrade and Industry Ministers on proposals itreceives from insurance providers and thesubsequent level of compliance by theindustry. GAIC will publish an annual reportcontaining details of tests reviewed and ofinsurers’ compliance with the Concordat,Moratorium and ABI Code of Practice.

32. GAIC will liaise with the clinical geneticscommunity, patient groups and experts ininsurance and actuarial sciences. GAIC willmonitor and publish trends on the nature andvolume of NHS predictive genetic testing forlate-onset, high penetrance single geneconditions, such as Huntington’s Disease.It will also work with HGC to provide ahorizon-scanning capability for potential futuredevelopments relevant to genetics andinsurance.

The Human Genetics Commission

33. HGC will continue to advise Ministers onthe ethical, legal and social implications ofwider developments in genetics and theirimplications for healthcare and the adequacyof the regulatory framework that applies tohuman genetics. It will work closely with GAICwhere these considerations relate to geneticsand insurance.

Duration and review

34. The Concordat comes into effect on14 March 2005. It may be updated in thelight of experience, research findings anddevelopments in genetic technology, andclinical practice.

35. The Moratorium on insurers’ useof predictive genetic tests dating from1 November 2001 will be extended by anextra five years until 1 November 2011.

36. There will be a review of the operationof this Concordat and Moratorium in 2008.


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